Multistage bioabsorbable plug system and method of insertion

ABSTRACT

A system and method for sealing openings in a body of a patient made by a medical procedure or non-medical event. The opening may be formed in soft tissue, internal organs, or hard tissue. A coaxial needle is inserted into a patient and a coagulating agent is inserted into the patient via the coaxial needle. The coagulating agent is discharged adjacent to the opening and the coaxial needle is inserted to a surgical depth. Following the procedure, the coaxial needle is retracted to a plug discharging depth. A bioabsorbable plug in at least a partially dehydrated state is then discharged from the coaxial needle and the coaxial needle is removed. The plug resides at least partially within the opening in the organ or tissue created by the coaxial needle. The combination of the coagulating agent and the expandable plug seals the opening created by the coaxial needle.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates, generally, to sealing tissue. More specifically,it relates to a multistage bioabsorbable plug system and method ofinsertion.

2. Brief Description of the Prior Art

Numerous medical procedures and even non-medical events can result inopenings in the body that need to be sealed to stop bodily fluids and/orgaseous fluids from exiting the body. For example, sealing means forclosing openings are needed to stop the flow of blood, cerebral spinalfluid, air, and other fluids. These sealing means are particularlyimportant when it comes to stopping the flow of fluids from organs.

For exemplary purposes, consider an opening made by a biopsy needle. Ina biopsy procedure, a needle adapted to collect tissue is inserted intoa suspected lesion, usually multiple times. When a sufficient quantityof the lesion has been collected, the samples are taken to a lab foranalysis. To perform the procedure, a coaxial needle first punctures thebody/tissue and inserted so that its leading/distal end is positionednear the suspected lesion. A biopsy needle is then inserted through thecoaxial needle and samples are collected.

The puncture opening made by the coaxial needle may close and healnaturally if the lesion is in soft tissue such as a breast. However, ifa lesion is in the lung or any other internal organs, the punctureopening made by the coaxial needle may need to be closed quickly. Infact, air leaks (“pneumothorax”) commonly occur at pulmonary tissuesites that have been biopsied or dissected during surgical resection andmanipulation.

Obviously, an opening in a lung is undesirable because air can leaktherefrom and cause the lung to collapse. In fact, it is estimated thatpneumothorax occurs in about thirty percent (30%) of lung biopsies.Openings in other organs, such as the heart, liver, kidney, and the likeare also undesirable due to excess bleeding and other related problems.

Existing bioabsorbable sealant plugs and delivery methods, such as thosein U.S. Pat. Nos. 6,790,185; 7,001,410; 6,685,727; 6,592,608; and U.S.Pat. No. 7,329,414 to the same inventors proved to be beneficial inreducing pneumothorax. However, pneumothorax still occurred in about 30%of lung biopsies in which these patented plugs and methods were used.Specifically, these plugs and methods are unable to account for smalltears in the lungs that sometimes occur during the initial insertion(i.e., puncturing) of a needle through the pleura in a patient's lung.

Other disclosures, such as publication WO2019138019A2 rely solely on ahydrogel and teach away from the use of blood. Specifically, saidpublication states that the use of blood to prevent pneumothorax has“proven ineffective and [has] not been widely adopted. [The] lack ofefficacy may be as [sic] a result of the physical properties of thesubstances injected and the lack of control over their injectedlocation.” Accordingly, these disclosures teach away from the presentinvention as will be described herein. Accordingly, what is needed is animproved bioabsorbable plug system and method of use to further reducethe occurrences of pneumothorax and better seal openings in other organsand tissue. However, in view of the art considered as a whole at thetime the present invention was made, it was not obvious to those ofordinary skill in the field of this invention how the shortcomings ofthe prior art could be overcome.

All referenced publications are incorporated herein by reference intheir entirety. Furthermore, where a definition or use of a term in areference, which is incorporated by reference herein, is inconsistent orcontrary to the definition of that term provided herein, the definitionof that term provided herein applies and the definition of that term inthe reference does not apply.

While certain aspects of conventional technologies have been discussedto facilitate disclosure of the invention, Applicants in no way disclaimthese technical aspects, and it is contemplated that the claimedinvention may encompass one or more of the conventional technicalaspects discussed herein.

The present invention may address one or more of the problems anddeficiencies of the prior art discussed above. However, it iscontemplated that the invention may prove useful in addressing otherproblems and deficiencies in a number of technical areas. Therefore, theclaimed invention should not necessarily be construed as limited toaddressing any of the particular problems or deficiencies discussedherein.

In this specification, where a document, act or item of knowledge isreferred to or discussed, this reference or discussion is not anadmission that the document, act or item of knowledge or any combinationthereof was at the priority date, publicly available, known to thepublic, part of common general knowledge, or otherwise constitutes priorart under the applicable statutory provisions; or is known to berelevant to an attempt to solve any problem with which thisspecification is concerned.

BRIEF SUMMARY OF THE INVENTION

The long-standing but heretofore unfulfilled need for an improvedbioabsorbable plug system and method of use to further reduce theoccurrences of pneumothorax and better seal openings in other organs andtissue is now met by a new, useful, and nonobvious invention.

Some embodiments of the multistage bioabsorbable plug system comprise acoaxial needle, a coagulating agent, and a plug. The coaxial needle hasa plug discharge port and a coagulating agent discharge port. In someembodiments, the ports are the same, while in others, they are distinctports.

In some embodiments, the coagulating agent is a fluidic solution.Moreover, the coagulating agent is biocompatible.

During use, the coagulating agent is inserted within an organ throughthe coaxial needle following insertion of the coaxial needle within theorgan. In some embodiments, the coagulating agent includes blood fromthe patient. In some embodiments, the coagulating agent is 10 cc ofblood.

In some embodiments, the plug is a biocompatible hydrogel and isconfigured to expand upon contact with an aqueous fluid. In someembodiments, the plug is configured to absorb the coagulating agent.During use, the plug is inserted at least partially into a wall of theorgan in at least a partially dehydrated state via the coaxial needle.The combination of the fluidic coagulating agent and the plug seals ahole in the organ wall created by the coaxial needle when the coaxialneedle is withdrawn from the organ.

The method of present invention includes sealing an organ, such as alung/pleura, in a patient. The method may include determining a distancebetween a patient's skin and the pleura. A coaxial needle can then beinserted through the patient's skin. The coaxial needle has acoagulating agent discharge port through which a coagulating agent canbe discharged into the patient and a plug from the plug discharge portthrough which the plug can be delivered.

The method further includes bringing the coaxial needle to an initiallocation in which the coagulating agent discharge port is 2 cm or lessin distance from the pleura. While the coaxial needle is at the initiallocation, the coagulating agent is injected into the patient via thecoaxial needle, such that the coagulating agent exits the coagulatingagent discharge port. After insertion of the coagulating agent, thecoaxial needle is advanced to a surgical location and a surgicalprocedure can be performed.

Following the surgical procedure, the coaxial needle is retracted to aplug discharging depth, wherein the plug discharging depth includes aplug discharge port within 2 cm from an internal surface of the pleura.Then the plug is discharged from the plug discharge port whileretracting the coaxial needle, such that the plug resides at leastpartially within the pleura. The plug is comprised of a biocompatiblehydrogel configured to expand upon contact with an aqueous fluid, suchas bodily fluids or the coagulating agent. After the plug is inserted,the coaxial needle is withdrawn from the patient.

Some embodiments include the plug being inserted into the coaxial needlein a dehydrated state. Some embodiments include pre-hydrating the plugprior to discharging the plug from the plug discharge port.

Some embodiments further include a step of retrieving blood from thepatient and using the blood as the coagulating agent. In someembodiments, the coagulating agent is 10 cc of blood. Some embodimentsfurther include a step of injecting the coagulating agent when thecoaxial needle is at the plug discharging depth.

In some embodiments, the initial location of the coaxial needle includesa portion of the coaxial needle having passed through the pleura. Insome embodiments, the initial location of the coaxial needle includesthe coagulating agent discharge port residing within the pleura.

These and other important objects, advantages, and features of theinvention will become clear as this disclosure proceeds.

The invention accordingly comprises the features of construction,combination of elements, and arrangement of parts that will beexemplified in the disclosure set forth hereinafter and the scope of theinvention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the invention, reference should be made tothe following detailed description, taken in connection with theaccompanying drawings, in which:

FIG. 1 is a diagram of a coaxial needle having penetrated a patient'sskin and pleura.

FIG. 2 is an illustration of radial tears resulting from inserting acoaxial needle through a section of a pleura.

FIG. 3 is a diagram illustrating a step of inserting coagulating agentwithin a pleura after the coaxial needle has penetrated a patient's skinand pleura.

FIG. 4 is a diagram illustrating a step of inserting coagulating agentoutside of a pleura after the coaxial needle has penetrated a patient'sskin and pleura.

FIG. 5 is a diagram illustrating a step of inserting coagulating agentwithin and outside of a pleura.

FIG. 6 is a diagram illustrating a step of advancing the coaxial needleto a surgical depth proximate to the tissue to be sampled.

FIG. 7 is a diagram illustrating a step of inserting a plug within apleura.

FIG. 8 is a diagram showing the plug just after the coaxial needle hasbeen retracted from the pleura.

FIG. 9 is a diagram showing the plug during expansion after the coaxialneedle has been retracted from the pleura.

FIG. 10 is an exemplary flowchart of an embodiment of the presentinvention.

FIG. 11 is a diagram of a coaxial needle having a laterally disposedcoagulating agent discharge port after the coaxial needle has penetrateda patient's skin and pleura.

FIG. 12 is a diagram of a coaxial needle having a multiple laterallydisposed coagulating agent discharge ports after the coaxial needle haspenetrated a patient's skin and pleura.

FIG. 13 is an embodiment of a plug delivery housing.

FIG. 14 is an embodiment of a plug delivery housing.

FIG. 15 is an embodiment of a plug delivery housing.

FIG. 16 is an embodiment of a plug delivery housing.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description of the preferred embodiments,reference is made to the accompanying drawings, which form a partthereof, and within which are shown by way of illustration specificembodiments by which the invention may be practiced. It is to beunderstood that other embodiments may be utilized, and structuralchanges may be made without departing from the scope of the invention.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the context clearly dictates otherwise.

The phrases “in some embodiments,” “according to some embodiments,” “inthe embodiments shown,” “in other embodiments,” and the like generallymean the particular feature, structure, or characteristic following thephrase is included in at least one implementation. In addition, suchphrases do not necessarily refer to the same embodiments or differentembodiments.

As used herein, “biocompatible” means bioabsorbable, biodegradable, orresorbable.

The present invention includes a multistage bioabsorbable plug systemand method of use. The system is comprised of a coagulating agent and anexpandable plug. In some embodiments, the coagulating agent is anaqueous solution and the expandable plug is comprised of a non-liquid ornon-fluid material, but may be configured to absorb an aqueous solution.In other words, the coagulating agent is fluidic in nature with anability to flow as a fluid and no fixed shape prior to coagulation. Incontrast, the expandable plug has a definable shape and while someembodiments can absorb fluids, the plug itself has a gel-like,semisolid, or solid state.

Some embodiments of the method include initially delivering thecoagulating agent within an internal area of an organ/bodily cavityproximate the opening in the organ/cavity. A surgical procedure can thenbe performed and upon completion of the procedure, the expandable plugis inserted into the body adjacent to or within the opening in theorgan, and the surgical instrument is removed. The combination of thecoagulating agent and the plug seals the organ, thereby preventing theescape of bodily fluids.

Referring to FIG. 1, it will there be seen that the reference numeral 10denotes a biopsy site as a whole. Openings in a mammalian body may beformed by numerous other medical procedures and non-medical events asmentioned earlier. However, a biopsy procedure is explained forexemplary purposes. Furthermore, while the exemplary biopsy site islocated within a patient's lung, it should be understood that theutility of this invention is not restricted to sealing openings formedin lungs by biopsy procedures. Rather, this invention may be used toseal openings formed by any means in organs, such as the heart, brain,liver, spinal cord, and kidneys, and even in hard tissue such as bone,cartilage, and the like.

As depicted in FIG. 1, a typical coaxial needle 12 is used to puncturepatient's skin 21 and pleura 20 of the patient's lung. While thedepicted passage 22 of coaxial needle 12 through pleura 20 of thepatient's lung appears to be a clean circular hole generally equal tothe outer diameter of coaxial needle 12, in practice, the hole is oftenaccompanied by radial tears 24 in the tissue extending outwardly fromneedle passage 22 as depicted in FIG. 2. In such instances, theinsertion of a plug in passage 22 is incapable of sealing these tearsbecause the tears extend radially beyond the lateral expanse of theplug. Even the expanding hydrogel plug invented by the same inventorssometimes proved unable to seal these types of tears because the tearsoften extended radially beyond the lateral expanse of the hydrated plug.In addition, the delay in expansion of the plug sometimes resulted inthe substantial pneumothorax, which in turn resulted in the lungcollapsing.

As best depicted in FIG. 3, the present invention overcomes these issuesby depositing coagulating agent 26 that surrounds passage 22 and anyradially extending tears 24. The coagulating agent is then able to sealany radial tears 24 while a plug can be inserted into passage 22 uponcompletion of the surgical procedure.

In some embodiments, the coagulating agent is the patient's blood, whichmay have been retrieved prior to or during the surgical procedure. Thepatients' blood is highly advantageous as a peripheral sealant becauseit is safe to the patient with no risk of the patient having an allergicor adverse reaction to their own blood. In addition, since blood is 90%water and is located in close contact to the desiccated or partiallydesiccated plug, the blood will act as a source for the highconcentration of water immediately abutting the desiccated hydrogel plugto move via osmosis into the desiccated plug and could enhance the speedat which the plug expands to more rapidly fill the void of the biopsytract. As a result, the use of blood further reduces the sealing time ofthe multistage plug system in comparison with other coagulating agents.

In some embodiments, the coagulating agent is a blood clot derived fromthe patient. Moreover, the coagulating agent may be comprised of orinclude an adhesive or a coagulation catalyst. In some embodiments, thecoagulating agent is any agent known to a person of ordinary skill inthe art that is biocompatible and adapted to transition from a liquid toa gel-like, semisolid state, or solid state. Some examples include butare not limited hyaluronic acid, moisture sensitive curing hydrogel,two-part curing hydrogel, and adhesive.

In some embodiments, roughly 10 cc of coagulating agent is inserted onthe inside and/or the outside of the pleura/tissue barrier. Someembodiments, however, may use 10 cc to 20 cc of coagulating agentinserted on the inside and/or the outside of the pleura/tissue barrier.Some embodiments use at least 10 cc of coagulating agent inserted on theinside and/or the outside of the pleura/tissue barrier. In someembodiments, the volume of coagulating agent is dependent on thediameter of the coaxial needle.

In some embodiments, coagulating agent 26 is inserted proximate to theinternal surface of pleura 20 as shown in FIG. 3. In some embodiments,coagulating agent 26 is inserted proximate to the external surface ofpleura 20 as shown in FIG. 4. As shown in FIG. 5, some embodimentsinclude inserting coagulating agent 26 proximate to both the internaland external surfaces of pleura 20.

To ensure that the coagulating agent is deposited sufficiently proximateto the surfaces of pleura 20, a coagulating agent discharge port islocated within roughly 2 cm from the surface of the pleura. In someembodiments, the coagulating agent discharge port is located withinroughly 1 cm from the surface of the pleura.

In some embodiments, the coagulating agent is initially deposited uponinsertion of coaxial needle 12 through pleura 20. When the coagulatingagent is initially deposited upon insertion of coaxial needle 12 throughpleura 20, the coagulating agent has additional time to coagulate andcan even seal or partially seal any radial tears 24 prior to thecompletion of the surgical procedure.

However, some embodiments include the coagulating agent being depositedjust before or just after the plug is deposited within passage 22. Theplug is typically deposited after sufficient biopsy samples have beenretrieved and the biopsy needle has been removed from the coaxialneedle. Thus, some embodiments include the coagulating agent beingdeposited after the biopsy samples have been retrieved, but before thecoaxial needle is removed from the patient.

FIG. 6 depicts the advancement of coaxial needle 12 to an adjacentlocation to tissue 15. Once coaxial needle 12 is moved to this surgicaldepth, biopsy needle 34 can retrieve tissue samples from tissue 15.

As shown in FIGS. 7-8, after the biopsy samples have been retrieved, butbefore the coaxial needle 12 has been completely removed from thepleura, plug 28 is inserted into passage 22. Plug 28 is formed of amaterial that expands upon contact with a stimulant such as water,blood, air, visible light, or other electromagnetic radiation such as alaser beam, a preselected chemical, and so on. In a preferredembodiment, the stimulant is moisture which is naturally present on thesurface of a patient's lungs or other soft tissue, internal organs, orthe like.

Thus, some embodiments of plug 28 have a dehydrated or partiallydehydrated state and a hydrated state. Plug 28 is preferably configuredto expand and seal passage 22 almost immediately to prevent unnecessaryfluid loss through passage 22. While coagulating agent 26 may eventuallyseal passage 22, plug 28 helps expedite the process to account fordelays in coagulation time. Essentially, plug 28 removes the coagulationtime from consideration and allows a surgeon to almost immediately sealpassage 22 regardless of how much time is required for coagulation agentto coagulate.

Depicted plug 28 is generally a solid cylindrical shape to easily passthrough coaxial needle 12. In addition, plug 28 has a sufficient lengthto extend both inside and outside of pleura 20. In some embodiments,plug 28 has an elongated body that is not necessarily cylindrical.Moreover, plug 28 may have any cross-sectional shape, but preferably hasa length sufficient to extend both inside and outside of pleura 20.

In some embodiments, plug 28 is roughly 2.5 cm in length in a dehydratedstate and roughly 2 cm remains within pleura 20 and roughly 0.5 cmremains external to pleura 20 when plug 28 is in its inserted location.In some embodiments, plug 28 is roughly 3 cm in length in a dehydratedstate and roughly 2 cm remains within pleura 20 and roughly 1 cm remainsexternal to pleura 20 when plug 28 is in its inserted location. In someembodiments, the inserted location includes at least 0.5 cm extendinginternally or externally with respect to pleura 20.

In a dehydrated state, plug 28 has a cross-sectional area sufficient toallow plug 28 to pass through a lumen in coaxial needle 12. The hydratedstate includes plug 28 having an expanded cross-sectional area that isgreater than the cross-sectional area of coaxial needle 12 and passage22. Plug 28 further includes various cross-sectional sizes duringexpansion that are larger than the cross-sectional size when dehydratedand smaller than the cross-sectional size when fully hydrated.

Plug 28 may be discharged from lumen 18 using pusher rod 30 as coaxialneedle 12 is retracted out of pleura 20. This action is illustrated incomparing FIGS. 7 and 8. In some embodiments, the inserted location ofplug 28 includes part of plug 28 remaining within pleura 20 and part ofplug 28 located outside of pleura 20.

As shown in FIGS. 8 and 9, plug 28 is expands when contacted by aqueousfluids, such as biological fluids or coagulating agent 26. FIG. 9depicts plug 28 shortly after implantation and after having been incontact with moisture, or another predetermined stimulant, such thatplug 28 has at least partially expanded. The expansion effectively sealsthe peripheral edge of the puncture opening and prevents air fromescaping the lungs. In other applications, the plug is used to stopbleeding or other liquid fluid flow from the liver, heart, thecal sac,etc.

Plug 28 is also biocompatible, i.e., it is formed of a bioabsorbablematerial so that it is bioabsorbed by the body as the opening heals.Since people heal at different rates, a bioabsorbable material should beselected so that it is fully bioabsorbed in a period of time such as afew days to a few months.

Plug 28 may be comprised of any suitable bioabsorbable materials thatexpand when contacted by aqueous fluids including, but not limited tohydrogels, collagen, polysalactic acid, and any other suitablehydrophilic agents. Additional compositions include polymers that swellin the presence of aqueous fluids. Virtually all of the followingpolymers are hydrogels. Synthetic hydrogels can be prepared from thefollowing classes of polymers and these are generally considered to benon-biodegradable: poly(hydroxyalkyl methylacrylates), such aspoly(glyceryl methacrylate), poly(acrylamide), and poly(methacrylamide)and derivatives, poly(N-vinyl-2-pyrrolidone) anionic and cationichydrogelspoly(vinylalcohol)poly(ethylene glycol) diacrylate andderivatives from block copolymers composed of poly(ethyleneoxide)-poly(propyleneoxide)-poly(ethyleneoxide) andpoly(propyleneoxide)-poly(ethyleneoxide)-poly(propyleneoxide) blocks,respectively.

Biodegradable synthetic hydrogels can be prepared from polymers such asthose listed above by incorporating one or more of the followingmonomers: glycolide, lactide, E-caprolactone, P-dioxanone, andtrimethylene carbonate. In addition, biodegradable hydrogels can bebased on natural products such as polypeptides such as gelatin which maybe cross-linked with formaldehyde or glutaraldehyde and various otherdialdehydes.

Some other optional compositions include modified chitin hydrogels,which may be prepared from partially N-deacetylated chitin and thencross-linked with agents such as glutaraldehyde; dextran, apolysaccharide, derivatized with groups such as3-acryloyl-2-hydroxypropyl esters and subsequently cross-linked by freeradical copolymerization with N′,N′-methylenebisacrylamide; starch thatis similarly derivatized; and glycidyl acrylate followed by free radicalcross-linking as described above.

An embodiment of the novel method of the present invention isexemplified in FIG. 10 and corresponds to the illustrations in FIGS.3-9. As previously noted, while the examples provided herein pertain toa lung biopsy procedure, the method can be performed for other surgicalprocedures that involve the puncturing of other bodily structures and/ororgans.

Some embodiments include a first step 102 of acquiring one or moremedical images of the surgical site. The medical images may be acquiredby any imaging devices, including, but not limited to fluoroscopy,ultrasound, X-ray, magnetic resonance imaging, computed axial tomography(CAT) scanning, and other imaging techniques.

The images can be used to determine the distance between the patient'sskin and the wall of the organ (the pleura in the case of a lungbiopsy). That distance is then used in step 104 to guide the coaxialneedle to an initial location in which the distal end of the coaxialneedle is within a preferred distance from the wall of the organ. Insome embodiments, the preferred depth includes the distal end of thecoaxial needle being roughly 2 cm within the organ. In some embodiments,the distal end of the coaxial needle is between roughly 1 cm and 2 cmfrom the wall of the organ.

Some embodiments, however, include coaxial needle 12 having one or morecoagulating agent discharge ports 32 located in the lateral wall ofcoaxial needle 12 as shown in FIGS. 11 and 12. In such instances, thepreferred depth of coaxial needle 12 includes discharge ports 32 locatedwithin roughly 2 cm from organ wall 20. In some embodiments, thepreferred depth of coaxial needle 12 includes discharge ports 32 locatedbetween roughly 1 cm and 2 cm from organ wall 20.

As shown in FIG. 12, some embodiments include multiple coagulating agentdischarge ports 32A and 32B located in the lateral wall of coaxialneedle 12. Again, the preferred depth of discharge ports 32A and 32B isroughly 2 cm from organ wall 20. In some embodiments, the preferreddepth of coaxial needle 12 includes discharge ports 32A and 32B locatedbetween roughly 1 cm and 2 cm from organ wall 20.

Some embodiments of the coaxial needle that include laterally disposeddischarge ports also include a seal or membrane distally located fromthe discharge ports. The membrane is configured to seal the aperture inthe distal end of the coaxial needle to ensure that the coagulatingagent exits the discharge ports rather than the aperture in the distalend of the coaxial needle. The membrane is further configured to open inresponse to an actuator or in response to a needle or other surgicalinstrument applying a force to the internal/proximal surface of themembrane.

Some embodiments of the membrane include a plurality of triangularshaped flaps with the vertices of the triangles meeting generally in themiddle of the membrane. A needle can be forced through the meeting pointof the vertices and the triangular sections of the membrane give way tothe advancing needle. In some embodiments, the flaps are of a differentshape so long as they collectively act to seal the lumen of the coaxialneedle. In some embodiments, the flaps are made of a flexible material.In addition, the flaps are preferably in overlapping or in a sealablerelationship with each other when not subject to the external force of aneedle or surgical instrument.

Referring back to FIG. 10, at step 106, once coaxial needle 12 reachesits initial insertion depth, coagulating agent 26 is forced through theinternal lumen 18 of coaxial needle 12 and deposited proximate topassage 22 as shown in FIGS. 3-5. Some embodiments include injectingcoagulating agent through coaxial needle 12 via primary lumen 18 orthrough one or more secondary lumens connected to discharge port(s) 32.The coagulating agent is delivered proximate to the organ wall based onthe type of coaxial needle in use and the preferred initial location ofthe discharge ports/distal end of the coaxial needle.

The amount and composition of the coagulating agent used in the novelmethod may be any of those described herein. In addition, the locationof the coagulating agent may be in line with those described herein.Likewise, the plug used in the novel method may be any size, shape andcomposition disclosed herein.

After the coagulating agent has been injected, at step 108, coaxialneedle 12 is further advanced into the patient to bring distal end 14 ofcoaxial needle 12 into contact with or within a preferred proximity tothe tissue intended to be sampled (referred to hereinafter as “sampletissue 15”) as shown in FIG. 6. The surgical procedure, such as a tissuebiopsy, is then performed at step 110. When a sufficient amount ofbiopsy samples has been retrieved, the biopsy needle is withdrawn fromcoaxial needle 14. Then, at step 112, coaxial needle 12 is retracted toa plug insertion depth and held at this location while plug 28 isinserted and moved to distal end 14.

The plug insertion depth is illustrated in FIG. 7. In some embodiments,the plug insertion depth of coaxial needle 12, includes distal end 14roughly 2 cm within pleura 20. In some embodiments, the plug insertiondepth includes distal end 14 between roughly 0.5 cm and 2.5 cm withinpleura 20. Preferably the plug insertion depth includes distal end 14being a predetermined distance from pleura 20 that is equal to or lessthan the length of plug 28 to ensure that plug 28 resides at leastpartially within passage 22 in pleura 20.

Once coaxial needle 12 is located at the plug insertion depth, plug 28is discharged from coaxial needle 12 at step 114 to deliver plug 28within or adjacent to passage 22. In some embodiments, as depicted inFIGS. 7-8, pusher rod 30 is used to force plug 28 from lumen 18 incoaxial needle 12. Specifically, pusher rod 30 is held in place whencoaxial needle 12 is withdrawn to ensure that plug 28 does not move.Plug 28 may be delivered by any suitable pushing means or installed byany other suitable method. The particular method of installation maydepend upon the type of opening being plugged.

After plug 28 has been delivered, coaxial needle 12 is withdrawn fromthe patient at step 116, the action of which is exemplified in FIGS.8-9. The stimulus then causes expansion of the plug and sealing of theopening made by the needle.

Some embodiments include a step of inserting the coagulating agent afterthe plug has been delivered. Some embodiments include insertingcoagulating agent before and after the plug is delivered. In someembodiments, the coaxial needle has one or more side ports and lateraldischarge ports such that the plug and coagulating agent can bedelivered simultaneously.

In some embodiments, the plug is pre-hydrated prior to insertion intothe patient. The pre-hydration reduces the time necessary for the plugto reach its maximum expansion. In some embodiments, the plug ispre-hydrated to 25% of its maximum expansion. In some embodiments, theplug is pre-hydrated to between 10% and 30% of its maximum expansion. Insome embodiments the plug is pre-hydrated for roughly 5 minutes. In someembodiments the plug is pre-hydrated for roughly 3 minutes to 10minutes.

The pre-hydration step may be accomplished using one or more plugdelivery housings 40, such as those exemplified in FIGS. 13-16. Plugdelivery housing 40 includes main body 42 with proximal connector 44 anddistal connector 46. Bore 48 extends longitudinally through main body 42and connectors 44 and 46. Bore 48 is sized to receive and temporarilyhouse plug 28 in a dehydrated or partially hydrated state. In someembodiments, one or both of connectors 44 and 46 include threads toengage a complementary thread on an insertion instrument, such as aninsertion needle.

During the pre-hydration step, plug delivery housing 40, with an alreadyinserted plug 28, is deposited into an aqueous solution or brought intocontact with an aqueous solution to allow plug 28 to beginpre-hydrating. As best shown in FIGS. 14 and 16, some embodiments ofplug delivery housing 40 include one or more hydration channels 50.Hydration channels 50 extend generally in a lateral direction andprovide a fluidic passageway to deliver aqueous solution to bore 48 andin turn plug 28 to allow for quicker and more consistent pre-hydrationof plug 28.

As shown in FIG. 15, some embodiments of plug delivery housing 40include distal connector 46 having a cavity or a distal portion 48 a ofbore 48 having a larger diameter than the other proximal sections ofbore 48. As a result, distal section 28 a of plug 28 is able to hydrateand expand to a larger extent than the remaining sections of plug 28. Asa result, distal section 28 a is less likely to accidentally passthrough passage 22 when coaxial needle 12 is removed. Essentially,distal section 28 a acts an expanded anchor.

As shown in FIG. 16, the same result can be achieved by extending distalsection 28 a outside of bore 48 prior to pre-hydrating plug 28. Again,distal section 28 a of plug 28 is able to hydrate and expand to agreater size than the remaining sections of plug 28. As a result, distalsection 28 a acts an expanded anchor to reduce the likelihood of distalsection 28 a accidentally passing through passage 22 when coaxial needle12 is removed.

Accordingly, in some embodiments, the pre-hydration step includespositioning distal section 28 a of plug 28 in cavity 48 a or distallyoutside of bore 48 prior to plug 28 contacting an aqueous solution.Moreover, it should be noted that while FIGS. 13-16 show differentembodiments with different features, embodiments of plug deliveryhousing 40 may include any combination of the depicted features.

Some embodiments of the novel method of the present invention furtherinclude a step of extracting a patient's blood and then using theextracted blood as the coagulating agent. In some embodiments, the bloodis modified. For example, additional adhesives or coagulation catalystsmay be added to the patient's blood.

The advantages set forth above, and those made apparent from theforegoing description, are efficiently attained. Since certain changesmay be made in the above construction without departing from the scopeof the invention, it is intended that all matters contained in theforegoing description or shown in the accompanying drawings shall beinterpreted as illustrative and not in a limiting sense.

It is also to be understood that the following claims are intended tocover all of the generic and specific features of the invention hereindescribed, and all statements of the scope of the invention that, as amatter of language, might be said to fall therebetween.

What is claimed is:
 1. A method of sealing a pleura in a patient,comprising: determining a distance between a patient's skin and thepleura; inserting a coaxial needle through the patient's skin, whereinthe coaxial needle has a coagulating agent discharge port through whicha coagulating agent can be discharged into the patient; bringing thecoaxial needle to an initial location in which the coagulating agentdischarge port is 2 cm or less in distance from the pleura; while thecoaxial needle is at the initial location, injecting coagulating agentinto the patient via the coaxial needle, such that the coagulating agentexits the coagulating agent discharge port, wherein the coagulatingagent is comprised of blood; after injecting the coagulating agent,advancing the coaxial needle to a surgical location and performing asurgical procedure; following the surgical procedure, retracting thecoaxial needle to a plug discharging depth, wherein the plug dischargingdepth includes a plug discharge port within 2 cm from an internalsurface of the pleura; discharging a plug from the plug discharge portwhile retracting the coaxial needle, such that the plug resides at leastpartially within the pleura, wherein the plug is comprised of abiocompatible hydrogel configured to expand upon contact with an aqueousfluid; and withdrawing the coaxial needle from the patient.
 2. Themethod of claim 1, further including pre-hydrating the plug prior todischarging the plug from the plug discharge port.
 3. The method ofclaim 1, wherein the plug is inserted into the coaxial needle in adehydrated state.
 4. The method of claim 1, further including retrievingblood from the patient and using the blood as the coagulating agent. 5.The method of claim 1, wherein the coagulating agent is 10 cc of blood.6. The method of claim 1, wherein the initial location of the coaxialneedle includes a portion of the coaxial needle having passed throughthe pleura.
 7. The method of claim 1, wherein the initial location ofthe coaxial needle includes the coagulating agent discharge portresiding within the pleura.
 8. The method of claim 1, further includinginjecting the coagulating agent when the coaxial needle is at the plugdischarging depth.
 9. The method of claim 1, wherein the plug isconfigured to absorb the coagulating agent.
 10. A method of sealing apleura in a patient, comprising: determining a distance between apatient's skin and the pleura; inserting a coaxial needle through thepatient's skin and the pleura, wherein the coaxial needle has acoagulating agent discharge port through which a coagulating agent canbe discharged into the patient; bringing the coaxial needle to aninitial location in which the coagulating agent discharge port resideswithin the pleura; while the coaxial needle is at the initial location,injecting coagulating agent into the patient via the coaxial needle,such that the coagulating agent exits the coagulating agent dischargeport and is delivered within the pleura; after injecting the coagulatingagent, advancing the coaxial needle to a surgical location andperforming a surgical procedure; following the surgical procedure,retracting the coaxial needle to a plug discharging depth, wherein theplug discharging depth includes a plug discharge port within 2 cm froman internal surface of the pleura; discharging a plug from the plugdischarge port while retracting the coaxial needle, such that the plugresides at least partially within the pleura, wherein the plug iscomprised of a biocompatible hydrogel configured to expand upon contactwith an aqueous fluid; and withdrawing the coaxial needle from thepatient.
 11. The method of claim 10, further including pre-hydrating theplug prior to discharging the plug from the plug discharge port.
 12. Themethod of claim 10, wherein the plug is inserted into the coaxial needlein a dehydrated state.
 13. The method of claim 10, further includingretrieving blood from the patient and using the blood as the coagulatingagent.
 14. The method of claim 10, wherein the coagulating agent is 10cc of blood.
 15. The method of claim 10, further including injecting thecoagulating agent when the coaxial needle is at the plug dischargingdepth.
 16. The method of claim 10, wherein the plug is configured toabsorb the coagulating agent.